Glenmark gets USFDA nod for chest pain tablets

NEW DELHI: Glenmark Pharmaceuticals today said its US arm has received final approval from USFDA for its Nitroglycerin sublingual tablets used for preventing chest pain due to coronary artery disease. Glenmark Pharmaceuticals Inc has received final approval by the US health regulator for Nitroglycerin sublingual tablets USP in the strengths of 0.3 mg, 0.4 mg, and 0.6 mg, the company said in a statement. The tablets are generic versions of Pfizer Inc's Nitrostat sublingual tablets in the same strengths, it added. According to IMS health sales data for the 12 months ended July, the Nitrostat sublingual tablets 0.3 mg, 0.4 mg, and 0.6 mg (brand and all available therapeutic equivalents) achieved annual sales of around USD 112.7 million, Glenmark said. The company's current portfolio consists of 125 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDAs) which are pending approval with the USFDA, it added. Shares of Glenmark Pharmaceuticals were at Rs 612.25 per scrip in the afternoon trade on BSE, down 0.52 per cent from previous close.

Related

NEW DELHI: Glenmark Pharmaceuticals has received final nod from the US health regulator for generic oral contraceptive Levonorgestrel/Ethinyl Estradiol tablets and plans to commence shipping of the product immediately. Glenmark Pharmaceuticals USA has been granted final approval by the United States Food & Drug Administration (USFDA) for the "extended-cycle oral contraceptive Levonorgestrel and Ethinyl Estradiol tablets USP 0.15 mg/0.03 mg," Glenmark Pharmaceuticals said in a statement. The product is the generic version of Teva Women's Health's Seasonale tablets, it added.

NEW DELHI: Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for oral contraceptives and leukemia treatment injection. "Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for drospirenone and ethinyl estradiol... and for levonorgestrel tablets," it said in a BSE filing. Drospirenone and ethinyl estradiol are generic version of Bayer Healthcare's Yasmin tablets and levonorgestrel tablets is generic version of Teva Branded Pharmaceutical Products' Plan B one-Step tablets.

NEW DELHI: Glenmark Pharmaceuticals has received the final nod from the US health regulator for a generic version of anti-bacterial drug Zyvox. "Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the US Food & Drug Administration (USFDA) for the Linezolid tablets, 600 mg," Glenmark Pharmaceuticals said in a statement. The product is the therapeutic equivalent of Zyvox tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer, it added.

NEW DELHI: Glenmark Pharmaceuticals has received tentative nod from the US health regulator for generic version of oral contraceptive tablets Lo Loestrin Fe. Glenmark Pharmaceuticals USA has been granted tentative approval by the USFDA for Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol tablets USP, 0.01 mg and Ferrous Fumarate tablets, 75 mg, the generic version of Lo Loestrin Fe, the company said in a BSE filing today.

NEW DELHI: Glenmark Pharma has received final approval from the US health regulator for its cream used for treatment of fungal skin infections. "Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Clotrimazole and Betamethasone Dipropionate cream USP, 1%|0.05%," the company said in a statement. The product is generic version of Merck, Sharp and Dohme Corporation's Lotrisone cream in the same strength, it added.

NEW DELHI: Glenmark Pharmaceuticals today said it has received the final approval from US health regulator for its generic version of desmopressin acetate tablets used in treatment of diabetes and bed-wetting. The approval by the US Food and Drug Administration (USFDA) is for strengths of 0.1 mg and 0.2 mg and the company plans to commence shipping the tablets to the US immediately, the pharma company said in a statement. Desmopressin Acetate is sold under the trademark DDAVP by Ferring Pharmaceuticals.

Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Rythmol SR capsules, an anti-arrhythmic medication, which treats illnesses associated with rapid heart beats. "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Propafenone Hydrochloride extended-release capsules USP, 225 mg, 325 mg, and 425 mg," Glenmark Pharmaceuticals said in a BSE filing. Propafenone Hydrochloride extended-release capsules is generic version of GlaxoSmithKline, LLC's Rythmol Capsules.

NEW DELHI: Glenmark Pharmaceuticals has received final approval from the US health regulator for Acyclovir Ointment used for treatment of herpes virus. "Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Acyclovir Ointment USP, 5 per cent, the generic version of Zovirax Ointment, 5 per cent, of Valeant International Bermuda," Glenmark Pharmaceuticals said in a BSE filing.

NEW DELHI: Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for anti-fungal ointment nystatin and triamcinolone acetonide. Glenmark Pharmaceuticals USA has been granted final approval by the US Food & Drug Administration (USFDA) for the "nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/g," the company said in a BSE filing. The product is the generic version of Mycolog-II cream of Declor Asset Corporation, it added.

NEW DELHI: Glenmark Pharmaceuticals has received tentative approval from the US health regulator for generic Calcipotriene cream, used for the treatment of plaque psoriasis. It said in a statement that Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Calcipotriene cream, 0.005 per cent. The product is the therapeutic equivalent of Danish pharma firm Leo Pharma A/S Dovonex's topical cream of the same strength, it added.